Bringing the Clinical Trial to the Patient

There was a time when the idea of clinical trial visits taking place anywhere other than the investigator site clinic would have been considered blue-sky thinking. That time is over, and more and more research companies are looking at ways to bring clinical trials to the patient rather than the other way around.

The driving force is convenience, says Nicki Norris, CEO of Symphony Clinical Research. “Making it more convenient to participate in a clinical research study means people are more likely to enroll and to stay in the study. When that happens, pharma companies are able to bring their products to market much sooner.”

Norris has helped to pioneer alternate-site services for clinical trials since arriving at Symphony in 2009. This includes direct-to-patient, in-home and alternate site clinical services, mobile nursing, ambulant care services and virtual trials.

This move towards greater patient-centricity was a direct response to the global financial crisis of 2008, says Norris. “Sponsoring pharma companies were told their drug development model was not sustainable, so they started looking for new ways of doing things, forced to by the financial markets. Outsourcing was one of the trends that stemmed from that shift, another was patient-centric practices in clinical research. The industry is still exploring and adopting these concepts.”

The in-home visit has changed the face of clinical trials, she says. “By associating the clinical trial process with a place of comfort and convenience, with caring and compassion delivered by the homecare clinician, it’s practically the definition of patient centricity – and it’s really working.”

The global success of Symphony’s services is due, in no small part, to Norris, who has over 30 years’ experience working in healthcare across a range of companies, including 20 years at Baxter Healthcare.

“You have to determine what is most valuable to your customers through open and honest communication,” she says. This includes listening to pharma company and CRO input and feedback, positive or negative; equally critical is working to identify risks early in the process so challenges can be optimally managed or completely avoided all together, she adds.

Many study sponsors initially considered in-home and alternate site services as high-risk endeavors, says Norris. In addition, investigator sites felt sponsors were “taking something away”, rather than adding value to their recruitment and retention goals.

“Back in 2009, we heard customers telling us that they’d never heard of it being done, or that it couldn’t be done, so we had a network of healthcare attorneys to examine the process more closely, and they found nothing to prevent it, from a regulatory perspective.”

This skepticism is still a challenge today, especially as larger clinical studies move into newer territories in Asia and Eastern Europe, she adds.

By continually reviewing processes and procedures, the company has identified many of the risks that can impede in-home visits. “Something as simple as recognizing that the nurse doesn’t have extra supplies with him/her in the home, as they would at the site clinic, and supplementing the lab kit to include these additional supplies, can protect a sample and valuable data for the study,” says Norris.

Even with our improved processes, not all study visits can be carried out in the home. “If a study requires instruments that are not mobile, like an MRI, the patient must go to the clinic. Or, if a required procedure is outside the scope of the nursing license, it may be necessary to have those visits done at the investigator site by a physician,” she adds.

One of Symphony’s tag lines is ‘Changing the pace of clinical trials: fewer patients, faster to market. “By taking clinical research study visits to the patients at a convenient time and location, our pharma customers have found patients are much more willing to enroll in studies and are more willing to stay in the study. That avoids patient drop-outs and can see patients enrolled faster, ultimately getting a new drug to the people who need it so desperately more quickly,” says Norris.

Norris was recently named Customer Innovator at the eyeforpharma awards in Philadelphia. A member of the expert judging panel, Chris Sellin, Head of Operational Excellence & Analytics at Shire, commented: “She is an ardent advocate for patient care and a champion of in-home clinical trials to improve clinical trial patient recruitment and retention.

“We need more solutions like this to start treating patients as they deserve and need to be treated,” added Jill Donahue, author at EngageRx.

To find out more about this years award winners, visit the website here

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